Post-Breast Procedure Pain Syndrome Study

NCT01114984 | Withdrawn

• 1 other identifier: Pro00019341
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to better understand and characterize the pain that some patients experience after undergoing various breast surgeries, including breast biopsy, lumpectomy, mastectomy, mastectomy with reconstruction, cosmetic breast augmentation, and breast reduction.

Conditions

Breast; Mastectomy, Segmental

Keywords

Pain management; Radical mastectomy; Breast surgery; post-operative pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain using VRS

  prospective cohort evaluation of patients undergoing various breast surgery procedures, followed for a period of 6 months post-operatively, and assessed for post-operative breast pain.

  6 months

Secondary Outcomes (5)

• Opioid consumption obtained from the recorded data

  6 months

• Postoperative nausea and vomiting using a Verbal Rating Scale

  6 months

• Return to normal activities of daily living using follow up questionnaires

  6 months

• Patient satisfaction using a verbal rating scale from 0 to 100

  6 months

• Hospital stay

  up to 1 week

Study Arms (8)

10% after breast biopsy

Incidence Post-operative pain after breast surgery.

20% after lumpectomy

Incidence Post-operative pain after breast surgery

30% after simple mastectomy

Incidence Post-operative pain after breast surgery

50% after mastectomy with reconstruction

Incidence Post-operative pain after breast surgery

50% after radical mastectomy

Incidence Post-operative pain after breast surgery

50% after radi mastectomy+reconstruction

Incidence Post-operative pain after breast surgery after radical mastectomy with reconstruction

40% after cosmetic augmentation

Incidence Post-operative pain after breast surgery

40% after breast reduction

Incidence Post-operative pain after breast surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergo breast surgery. (breast biopsy, lumpectomy, simple mastectomy,mastectomy with reconstruction, radical mastectomy, radical mastectomy with reconstruction, cosmetic augmentation and breast reduction)

You may qualify if:

• Patients scheduled to undergo one or more of the breast surgical procedures being studied for this project
• Willingness and ability to sign an informed consent document
• No allergies to anesthetic or analgesic medications
• Female,
• years of age
• ASA class I-III adult

You may not qualify if:

• Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
• Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, or history of chronic pain syndrome or neuropathy.
• Subjects with a history of alcohol or drug abuse within the past 3 months
• Subjects with a history of pain medication abuse
• Any other conditions or use of any medication which may interfere with the conduct of the study

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Roya Yumul, MD, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency program director, Department of anesthesiology

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: May 3, 2010
• Study Start: July 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 2, 2015

Record last verified: 2015-02

Locations

US (1)